Full Text View
Tabular View
No Study Results Posted
Related Studies
Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy
This study has been completed.
First Received: November 2, 1999   Last Updated: August 19, 2008   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000831
  Purpose

To elucidate the relationship between virologic risk factors and immunologic and clinical progression in patients receiving monotherapy in protocol ACTG 175, and to compare new treatment regimens with combinations of reverse transcriptase inhibitors in long-term recipients of monotherapy. Specifically, to determine, in patients who have been taking zidovudine (AZT) alone for a long time, whether it is beneficial to add lamivudine (3TC) to AZT or to switch to d4T alone, and also to determine, in patients who have been taking didanosine (ddI) alone for a long time, whether it is beneficial to add AZT or AZT/3TC to ddI.

Characteristics of virus replication, pathogenicity, and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response compared to continuation of AZT alone.


Condition Intervention Phase
HIV Infections
Drug: Lamivudine
Drug: Stavudine
Drug: Zidovudine
Drug: Didanosine
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 280
Detailed Description:

Characteristics of virus replication, pathogenicity, and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response compared to continuation of AZT alone.

Patients with prior AZT experience only are randomized to receive either d4T alone or AZT/3TC. Patients with prior ddI experience only are randomized to receive ddI/AZT or ddI/AZT/3TC. PER AMENDMENT 8/27/96: The study has been extended 6 months and treatment will be available until March 15, 1997 at the latest. Each patient will have regularly scheduled 12 week safety visits during the extension period.

AS PER AMENDMENT 1/22/97: The study has been extended for approximately 16 additional weeks beyond the current 6-month extension. Subjects will be unblinded to their assigned regimen beginning 2/21/97 and will continue therapy for up to 16 weeks in open-label fashion. AS PER AMENDMENT 5/9/97: The study has been extended for an additional 8 weeks; study drug will not be provided after 9/15/97.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Recommended:

  • PCP prophylaxis in patients with CD4 count <= 200 cells/mm3.

Allowed:

  • Chemophylaxis against Mycobacterium tuberculosis.
  • Acyclovir.
  • Vaccination with pneumococcal vaccine polyvalent.
  • Haemophilus B Conjugate vaccine.
  • Chemoprophylaxis for MAC and Toxoplasma gondii.
  • Antibiotics.
  • Recombinant erythropoietin ( EPO ) and G-CSF.
  • Systemic corticosteroids for < 21 days.
  • Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, and oral contraceptives.
  • Vitamins and herbal therapies.

Concurrent Treatment:

Allowed:

  • Limited local radiation therapy to skin.
  • Blood transfusions if 3 units or less per 21-day period.
  • Acupuncture.
  • Visualization techniques.

Patients must have:

  • Completed AZT or ddI monotherapy on ACTG 175 and remained on that regimen during any subsequent interval.
  • Not reached an ACTG 175 endpoint prior to May 1, 1995.
  • Consent of parent or guardian if less than 18 years old.

PER AMENDMENT 8/27/96:

  • Patients must be on study/on treatment at the time the protocol study treatment is extended.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Grade 2 or worse peripheral neuropathy.
  • Malignancy requiring systemic therapy.

Concurrent Medication:

Excluded:

  • Anti-HIV drugs other than study drugs.
  • Biologic response modifiers.
  • Systemic cytotoxic chemotherapy.
  • Any drug known to affect glucuronidation and/or clearance of AZT.

Concurrent Treatment:

Excluded:

  • Radiation therapy other than limited local therapy to skin.

Patients with the following prior condition are excluded:

  • History of acute or chronic pancreatitis.

Prior Medication:

Excluded:

  • Prior 3TC.
  • Acute therapy for an infection (other than HIV) or other medical illness within 14 days prior to study entry.

Current ethanol abuse.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000831

  Show 41 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: Katzenstein D
Study Chair: Hammer S
  More Information

Additional Information:
Publications:
Study ID Numbers: ACTG 302
Study First Received: November 2, 1999
Last Updated: August 19, 2008
ClinicalTrials.gov Identifier: NCT00000831     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Didanosine
Drug Therapy, Combination
AIDS-Related Complex
Antiviral Agents
Zidovudine
Stavudine
Lamivudine
Drug Combinations

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Stavudine
Molecular Mechanisms of Pharmacological Action
Zidovudine
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Didanosine
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on February 08, 2010